RayzeBio Safety MD Senior Director

Responsibilities

• Lead or co-lead global pharmacovigilance strategy, proactive safety surveillance, signal detection, risk management, and compliance with FDA, EMA, ICH, and other applicable regulations.
• Establish and maintain safety governance structures, SOPs, and continuous improvement processes aligned with company objectives and industry best practices.
• Partner with BMS safety, clinical development, regulatory, medical affairs, and cross-functional teams to integrate safety insights into product development, clinical trials, labeling, and risk minimization strategies.
• Direct safety evaluation and benefit-risk assessment for clinical development and post-marketing products, including AE profile management and product safety strategy.
• Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.
• Drive safety-related content for protocols, investigator brochures, DSURs, PSURs, RMPs, ICFs, RSLs, CSRs, regulatory filings, and responses to regulatory inquiries.
• Perform daily ICSR/SAE case reviews and support appropriate safety management across all phases of clinical trials.
• Serve as a key PV representative for global regulatory authorities, external experts, scientific bodies, and industry groups while advocating for patient safety.
• Mentor cross-functional colleagues, direct reports, and safety team members on core PV concepts and practices.
• Leverage AI to improve program, portfolio, or functional performance through prioritization and scaled adoption.
• Serve as backup Safety MD for the PV Head as needed.

Qualifications

• MD or equivalent
• 10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry.
• Demonstrated knowledge/awareness of existing/current global pharmacovigivalence regulations and guidelines, including FDA, EMA, and ICH.
• Demonstrated expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting.
• Experience interacting with global regulatory authorities and scientific advisory bodies.
• Radiopharmaceutical experience
• Oncology Safety experience
• NDA/MAA/JNDA submission experience